CN113730033B

CN113730033B - Sealing member for prosthetic heart valve

Info

Publication number: CN113730033B
Application number: CN202111060324.0A
Authority: CN
Inventors: T·S·列维
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2017-08-21
Filing date: 2018-08-20
Publication date: 2024-06-07
Anticipated expiration: 2038-08-20
Also published as: KR102619515B1; EP3672528B1; CN111163730A; CA3072239A1; US20240122702A1; US10722353B2; KR20200035160A; EP3964174B1; EP4591829A2; US11850148B2; CN111163730B; US20190053899A1; WO2019040364A1; US20200345488A1; EP4591829A3; EP3672528A4; CN113730033A; EP3964174A1; ES2900642T3; DK3672528T3

Abstract

The present application relates to a sealing member for an artificial heart valve. An implantable artificial valve can include: an annular frame including an inflow end and an outflow end, and radially contractible and expandable between a radially contracted configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end; a leaflet structure positioned within the frame and fixed thereto; and an external sealing member positioned around an outer surface of the frame, wherein the external sealing member includes a plurality of sealing segments, wherein each sealing segment is coupled to the frame and/or another sealing segment by a tether, and the tether pulls a portion of the sealing segment in a circumferential direction when the frame is radially expanded to the expanded configuration.

Description

Sealing member for prosthetic heart valve

The present application is a divisional application of chinese patent application 2018800639632 (PCT/US 2018/047071) entitled "sealing member for prosthetic heart valve" filed on 8/20 of 2018.

Technical Field

The present disclosure relates to implantable, expandable prosthetic devices (prosthetic device) and methods and apparatus for such prosthetic devices.

Background

The human heart may suffer from various valve diseases. These valve diseases can lead to serious dysfunction of the heart, ultimately requiring replacement of the native valve with a prosthetic valve. There are many known prosthetic valves and many known methods of implanting these prosthetic valves into the human body. Percutaneous and minimally invasive surgical methods are receiving considerable attention due to the shortcomings of conventional open-heart surgery. In one technique, a prosthetic valve (prosthetic valve) is configured to be implanted in a much less invasive manner by catheterization. For example, a collapsible (collapsible ) transcatheter prosthetic heart valve may be crimped to a compressed state and introduced percutaneously into the catheter in the compressed state and expanded to a functional size at a desired location by balloon inflation or with a self-expanding frame or stent.

Prosthetic valves used in such procedures may include a radially collapsible and expandable frame to which the leaflets of the prosthetic valve may be coupled and which may be introduced percutaneously over a catheter in a collapsed configuration and inflated by a balloon or expanded at a desired location with a self-expanding frame or stent. One challenge faced by prosthetic valves implanted in catheters is controlling paravalvular leakage around the valve, which may occur over a period of time following initial implantation. Another challenge includes a process of crimping such prosthetic valves into a profile suitable for percutaneous delivery to a patient.

Disclosure of Invention

Disclosed herein are embodiments of radially contractible and expandable prosthetic valves, including improved outer skirts for reducing paravalvular leakage, and related methods and apparatus including such prosthetic valves. In several embodiments, the disclosed prosthetic valves are configured as replacement heart valves for implantation in a patient.

In one representative embodiment, an implantable prosthetic valve can include an annular frame, a leaflet structure positioned within and secured to the frame, and an annular outer skirt positioned about an outer surface of the frame. The frame may include an inflow end and an outflow end, and may be radially contracted and expanded between a radially contracted configuration and a radially expanded configuration. The frame may define an axial direction extending from the inflow end to the outflow end. The outer skirt may include an inflow edge portion secured to the frame at a first location, an outflow edge portion secured to the frame at a second location, an intermediate portion between the inflow edge portion and the outflow edge portion, and a plurality of tethers. The intermediate portion may include a plurality of circumferentially spaced axially extending slits defining a plurality of skirt segments between each pair of slits, each skirt segment may include first and second opposed edge portions. Each tether may be secured to a first edge portion of a skirt segment at a first end of the tether, may extend through a second edge portion of the same skirt segment, and may be secured to the frame or an adjacent skirt segment at a second end of the tether such that the first edge portion is pulled by the tether in a circumferential direction toward the second portion when the frame expands to a radially expanded configuration.

In some embodiments, the second end of each tether may be secured to the frame.

In some embodiments, the second end of each tether may be secured to the frame adjacent the second edge portion of the skirt segment to which the first end of the tether is secured.

In some embodiments, the frame may include a plurality of struts, and the second end of each tether may be secured to the frame at the struts adjacent the second edge portion of the skirt section to which the first end of the tether is secured.

In some embodiments, each tether may be positioned radially outward of the skirt segment.

In some embodiments, each tether may be positioned radially inside the skirt segment.

In some embodiments, the tethers may include a first set of tethers positioned radially outward of the skirt segments and a second set of tethers positioned radially inward of the skirt segments.

In some embodiments, the tether may include a plurality of first tethers and a plurality of second tethers. In such embodiments, each first tether may have a first end secured to a first edge portion of a respective skirt segment, may extend through a second edge portion of the same skirt segment, and may have a second end secured to the frame at a first location. In such embodiments, each second tether may have a first end secured to the second edge portion of the respective skirt segment, may extend through the first edge portion of the same skirt segment, and may have a second end secured to the frame at a second location. In such embodiments, the first and second positions may be adjacent opposite sides of the skirt segment such that when the frame expands to the radially expanded configuration, the second tether pulls the second edge portion toward the first edge portion and the first tether pulls the first edge portion toward the second edge portion.

In some embodiments, the first tether may be positioned radially outside of the outer skirt and the second tether may be positioned radially inside of the outer skirt.

In some embodiments, the first tether and the second tether may each be positioned radially outward of the outer skirt.

In some embodiments, the first tether and the second tether may each be positioned radially inward of the outer skirt.

In some embodiments, the second end of each tether may be secured to an adjacent skirt segment.

In some embodiments, the plurality of tethers may include a plurality of first tethers and a plurality of second tethers. In such embodiments, each skirt segment may be coupled to a first adjacent skirt segment by a respective first tether and to a second adjacent skirt segment by a respective second tether such that when the frame expands to the radially expanded configuration, the first and second tethers pull the first and second edge portions of the skirt segments toward each other.

In some embodiments, for each skirt segment, a first tether may extend from a first edge portion of the skirt segment through a second edge portion and may be secured to a first adjacent skirt segment, and a second tether may extend from a second edge portion of the skirt segment through the first edge portion and may be secured to a second adjacent skirt segment.

In some embodiments, the first plurality of tethers may be positioned radially inward of the outer skirt and the second plurality of tethers may be positioned radially outward of the outer skirt.

In another representative embodiment, an implantable prosthetic valve can include an annular frame, a leaflet structure positioned within and secured to the frame, and an outer sealing member positioned about an outer surface of the frame. The frame may include an inflow end and an outflow end, and may be radially contractible and expandable between a radially contracted configuration and a radially expanded configuration. The frame may define an axial direction extending from the inflow end to the outflow end. The outer sealing member may comprise a plurality of sealing segments. Each seal segment may be coupled to the frame and/or another seal segment by a tether that pulls a portion of the seal segment in a circumferential direction as the frame radially expands to the expanded configuration.

In some embodiments, each seal segment may have upper and lower portions connected to the frame at axially spaced locations on the frame, the upper and lower portions moving toward each other upon radial expansion of the frame and causing a portion of the seal segment to move radially outward away from the frame.

In some embodiments, the width of each seal segment in the circumferential direction may be reduced by the tension of a tether attached to the seal segment as the frame radially expands.

In some embodiments, each seal segment may be at least partially twisted by the tension of a tether attached to the seal segment as the frame radially expands.

In some embodiments, each tether may have one end secured to a seal segment and another end secured to a frame or another seal segment.

The foregoing and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying drawings.

Drawings

Fig. 1-3 illustrate an exemplary embodiment of a prosthetic heart valve.

Fig. 4-10 illustrate an exemplary frame of the prosthetic heart valve of fig. 1.

Fig. 11-12 illustrate an exemplary inner skirt of the prosthetic heart valve of fig. 1.

Fig. 13 shows the prosthetic heart valve of fig. 1 in a contracted configuration and mounted on an exemplary balloon catheter.

Fig. 14-16 illustrate the assembly of the inner skirt of fig. 11 with the frame of fig. 4.

Figures 17-18 illustrate components of an exemplary leaflet structure.

Figure 19 shows an assembly of a commissure portion of a leaflet structure with a window frame portion of a frame.

Figures 20-21 illustrate the assembly of the leaflet structure with the inner skirt along the lower edge of the leaflet.

Fig. 22-23 illustrate various views of another exemplary outer skirt.

Fig. 24-25 illustrate an exemplary embodiment of a prosthetic heart valve frame using the outer skirt of fig. 22-23.

Fig. 26-27 illustrate another exemplary embodiment of a prosthetic heart valve frame using the outer skirt of fig. 22-23.

Fig. 28-29 illustrate another exemplary embodiment of a prosthetic heart valve frame using the outer skirt of fig. 22-23.

Fig. 30 shows an exemplary prosthetic heart valve implanted in a native aortic valve of a patient.

Fig. 31 shows an exemplary prosthetic heart valve and docking device implanted in a patient's pulmonary artery.

Fig. 32 illustrates an exemplary prosthetic heart valve and docking device implanted in a native mitral valve of a patient.

Fig. 33-34 illustrate an alternative embodiment of a docking device for a prosthetic valve.

Fig. 35 illustrates an exemplary prosthetic heart valve and the docking device of fig. 33-34.

Detailed Description

Fig. 1-3 illustrate various views of a prosthetic heart valve 10 according to one embodiment. The prosthetic valve shown is suitable for implantation in a native aortic annulus, although in other embodiments it may be suitable for implantation in other native annuluses of the heart (e.g., pulmonary, mitral, and tricuspid). The prosthetic valve may also be adapted for implantation into other tubular organs or passages within the body. The prosthetic valve 10 can have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a paravalvular sealing device or sealing member. The prosthetic valve 10 can have an inflow end portion 15, a middle portion 17, and an outflow end portion 19. In the illustrated embodiment, the paravalvular sealing device includes an outer skirt 18 (which may also be referred to as an outer sealing member).

The valve structure 14 may include three leaflets 41 that together form a leaflet structure, which may be arranged as a collapse in a tricuspid arrangement, as best shown in fig. 2. The lower edge of the leaflet structure 14 desirably has a wavy, curved scalloped shape (the sutures 154 shown in fig. 21 follow the scalloped shape of the leaflet structure). By forming the leaflets with such a scalloped geometry, the stress on the leaflets is reduced, which in turn improves the durability of the prosthetic valve. Furthermore, due to the fan shape, folds and waves at the abdomen of each leaflet (central region of each leaflet) which would lead to early calcification of these regions can be eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form the leaflet structure, thereby allowing for a smaller, more uniform crimping profile to be formed at the inflow end of the prosthetic valve. The leaflets 41 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic material, or various other suitable natural or synthetic materials known in the art and described in U.S. patent No.6,730,118.

The bare frame 12 is shown in fig. 4. The frame 12 may be formed with a plurality of circumferentially spaced slots or commissure windows 20 (three in the illustrated embodiment) adapted to connect commissures of the valve structure 14 to the frame, as described in more detail below. The frame 12 may be made of any of a variety of suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel titanium alloy (NiTi), such as nitinol). When constructed of a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) may be crimped into a radially-contracted configuration over the delivery catheter and then expanded within the patient by an inflatable balloon or equivalent expansion mechanism. When constructed from a self-expanding material, the frame 12 (and thus the prosthetic valve 10) may be crimped into a radially contracted configuration and constrained in the contracted configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced in and out of the delivery sheath, which allows the prosthetic valve to expand to its functional size.

Suitable plastically-expandable materials that may be used to form the frame 12 include, but are not limited to, stainless steel, biocompatible high strength alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In particular embodiments, the frame 12 is made of a nickel cobalt chromium molybdenum alloy, such asAlloy (SPS technologies, inc. of Zhenjin, pa.) which corresponds to UNS R30035 alloy (covered by ASTMF 562-02). /(I)The alloy/UNSR 30035 alloy contained by weight 35% nickel, 35% cobalt, 20% chromium and 10% molybdenum. WhenWhen the alloy is used as a frame material, less material is required to achieve the same or better radial and compressive forces, fatigue and corrosion resistance properties than stainless steel. In addition, because less material is required, the crimped profile of the frame may be reduced, thereby providing a lower profile prosthetic valve assembly for percutaneous delivery to a treatment site within the body.

Referring to fig. 4 and 5, the frame 12 in the illustrated embodiment includes: the angled struts 22 of the first lower row I are arranged end-to-end and extend circumferentially at the inflow end of the frame; a second row II of circumferentially extending angled struts 24; a third row III of circumferentially extending angled struts 26; a fourth row IV of circumferentially extending angled struts 28; and a fifth row V of circumferentially extending angled struts 32 at the outflow end of the frame. A plurality of substantially straight axially extending struts 34 may be used to interconnect the struts 22 of the first row I with the struts 24 of the second row II. The angled struts 32 of the fifth row V are connected to the angled struts 28 of the fourth row IV by a plurality of axially extending window frame portions 30 (which define the commissure windows 20) and a plurality of axially extending struts 31. Each axial strut 31 and each frame portion 30 extends from a position defined by the intersection of the lower ends of two angled struts 32 to another position defined by the intersection of the upper ends of two angled struts 28. Fig. 6, 7, 8, 9 and 10 are enlarged views of portions of the frame 12 identified by letters A, B, C, D and E, respectively, in fig. 5.

Each commissure window frame portion 30 is connected to a respective commissure of the leaflet structure 14. As shown, each frame portion 30 is secured at its upper and lower ends to adjacent rows of struts to provide a robust construction that enhances fatigue resistance under cyclic loading of the prosthetic valve as compared to cantilevered struts used to support commissures of the leaflet structure. This configuration enables a reduction in the thickness of the frame wall to achieve a smaller crimped diameter of the prosthetic valve. In certain embodiments, the thickness T (FIG. 4) of the frame 12 measured between the inner and outer diameters is about 0.48mm or less.

The struts and frame portions of the frame together define a plurality of open cells of the frame. At the inflow end of the frame 12, the struts 22, 24 and 34 define a lower row of cells defining openings 36. The struts 24, 26 and 28 of the second, third and fourth rows define two intermediate rows of cells defining openings 38. The fourth and fifth rows of struts 28 and 32, together with the frame portion 30 and struts 31, define an upper row of cells defining apertures 40. The openings 40 are relatively large and sized to allow portions of the leaflet structure 14 to protrude or bulge into and/or through the openings 40 when the frame 12 is crimped to minimize the crimping profile.

As best shown in fig. 7, the lower ends of the struts 31 are connected to the two struts 28 at nodes or joints 44, and the upper ends of the struts 31 are connected to the two struts 32 at nodes or joints 46. The post 31 may have a thickness S1 that is less than the thickness S2 of the engagement portions 44, 46. The engagement portions 44, 46 and the engagement portion 64 prevent complete closure of the aperture 40. Fig. 13 shows the prosthetic valve 10 crimped onto a balloon catheter. It can be seen that the geometry of strut 31 and the engagement portions 44, 46 and 64 help to create sufficient space in the aperture 40 in the contracted configuration to allow portions of the prosthetic leaflet to protrude or bulge outwardly through the aperture. This allows the prosthetic valve to be crimped to a relatively small diameter, rather than confining all of the leaflet material within the crimped frame.

The frame 12 is configured to reduce, prevent, or minimize possible over-expansion of the prosthetic valve at a predetermined balloon pressure, particularly at the outflow end portion of the frame supporting the leaflet structure 14. In one aspect, the frame is configured to have relatively large angles 42a, 42b, 42c, 42d, 42e between the struts, as shown in fig. 5. The larger the angle, the greater the force required to open (expand) the frame. Accordingly, the angle between struts of the frame may be selected to limit radial expansion of the frame at a given opening pressure (e.g., inflation pressure of the balloon). In certain embodiments, these angles are at least 110 degrees or greater when the frame is expanded to its functional size, and more specifically, up to about 120 degrees when the frame is expanded to its functional size.

Furthermore, the inflow and outflow ends of the frame are generally more prone to over-expansion than the middle portion of the frame due to the "dog bone" effect of the balloon used to expand the prosthetic valve. To prevent over-expansion of the leaflet structure 14, the leaflet structure is desirably secured to the frame 12 below the upper row of struts 32, as best shown in fig. 1. Thus, in the event that the outflow end of the frame is over-expanded, the leaflet structure is positioned below a level at which over-expansion may occur, thereby protecting the leaflet structure from over-expansion.

In one type of prosthetic valve structure, if the leaflets are attached too close to the distal end of the frame, a portion of the leaflets protrude longitudinally beyond the outflow end of the frame when the prosthetic valve is crimped. If the delivery catheter to which the crimped prosthetic valve is mounted includes a pushing mechanism or stop member that pushes against or abuts the outflow end of the prosthetic valve (e.g., to maintain the position of the crimped prosthetic valve on the delivery catheter), the pushing member or stop member may damage the portion of the exposed leaflets that extend beyond the outflow end of the frame. Another benefit of connecting the leaflets at a location spaced from the outflow end of the frame is that the outflow end of the frame 12, rather than the leaflets 41, are the most proximal component of the prosthetic valve 10 when the prosthetic valve is crimped onto the delivery catheter. Thus, if the delivery catheter includes a pushing mechanism or stop member that pushes against or abuts the outflow end of the prosthetic valve, the pushing mechanism or stop member contacts the outflow end of the frame, rather than the leaflets 41, in order to avoid damage to the leaflets.

Further, as shown in fig. 5, the openings 36 in the lowermost row of openings in the frame are relatively larger than the openings 38 in the middle two rows. This allows the frame to assume an overall conical shape when crimped, i.e. gradually decreasing from a maximum diameter at the outflow end of the prosthetic valve to a minimum diameter at the inflow end of the prosthetic valve. When crimped, the frame 12 may have a region of reduced diameter extending along a portion of the frame adjacent the inflow end of the frame, which generally corresponds to the region of the frame covered by the outer skirt 18. In some embodiments, the reduced diameter area is reduced as compared to the diameter of the upper portion of the frame (not covered by the outer skirt) such that the outer skirt 18 does not increase the overall crimping profile of the prosthetic valve. When the prosthetic valve is deployed, the frame may expand to a generally cylindrical shape as shown in fig. 4. In one example, when crimped, the frame of a 26mm prosthetic valve has a first diameter of 14French at the outflow end of the prosthetic valve and a second diameter of 12French at the inflow end of the prosthetic valve.

The primary function of the inner skirt 16 is to help secure the valve structure 14 to the frame 12 and to help form a good seal between the prosthetic valve and the native annulus by preventing blood from flowing through the open mesh of the frame 12 below the leaflet lower edge. The inner skirt 16 desirably comprises a tough tear resistant material such as polyethylene terephthalate (PET), although a variety of other synthetic or natural materials may be used (e.g., pericardial tissue). The thickness of the skirt is desirably less than about 0.15mm (about 6 mils), desirably less than about 0.1mm (about 4 mils), and even more desirably about 0.05mm (about 2 mils). In certain embodiments, the skirt 16 may have a variable thickness, e.g., the skirt may be thicker at least one edge thereof than at its center. In one embodiment, the skirt 16 may comprise a PET skirt having a thickness of about 0.07mm at its edges and about 0.06mm at its center. Thinner skirts may provide better crimping performance while still providing a good seal.

Skirt 16 may be secured to the interior of frame 12 by sutures 70, as shown in fig. 21. The valve structure 14 may be attached to the skirt by one or more reinforcement bands 72 (which may together form a sleeve) discussed below, such as a thin PET reinforcement band, which enables safe suturing and protects the pericardial tissue of the leaflet structure from tearing. The valve structure 14 may be sandwiched between the skirt 16 and a thin PET tape 72, as shown in fig. 20. The sutures 154 securing the PET tape and leaflet structure 14 to the skirt 16 may be any suitable suture, such as EthibondSuture (Johnson & Johnson, new Brunswick, new Jersey). Suture 154 desirably follows the curvature of the bottom edge of leaflet structure 14, as described in more detail below.

Some fabric skirts include a fabric of warp and weft fibers extending perpendicular to each other, wherein a set of fibers extends longitudinally between the upper and lower edges of the skirt. When a metal frame to which such a fabric skirt is fixed is radially crimped, the overall axial length of the frame increases. However, fabric skirts having limited elasticity cannot elongate with the frame, thus deforming the struts of the frame and preventing uniform crimping.

Referring to fig. 12, in one embodiment, skirt 16 is desirably woven from a first set of fibers or yarns or threads 78 and a second set of fibers or yarns or threads 80, neither of which are perpendicular to upper edge 82 and lower edge 84 of the skirt. In particular embodiments, the first and second sets of fibers 78, 80 extend at an angle of about 45 degrees (e.g., 15-75 degrees or 30-60 degrees) relative to the upper and lower edges 82, 84. For example, the skirt 16 may be formed by braiding fibers at a 45 degree angle relative to the upper and lower edges of the fabric. Alternatively, the skirt 16 may be cut (beveled) diagonally from a vertically woven fabric in which the fibers extend perpendicular to the edges of the material, such that the fibers extend at 45 degrees relative to the cut upper and lower edges of the skirt. As further shown in fig. 12, the relatively short edges 86, 88 of the skirt are desirably non-perpendicular to the upper and lower edges 82, 84. For example, the short edges 86, 88 desirably extend at an angle of about 45 degrees relative to the upper and lower edges and are thus aligned with the first set of fibers 78. Thus, the overall general shape of the skirt may be diamond or parallelogram.

Fig. 14 and 15 show the inner skirt 16 after the opposed short edge portions 90, 92 have been sewn together to form the annular shape of the skirt. As shown, the edge portions 90 may be placed in overlapping relation with respect to the opposing edge portions 92, and the two edge portions may be stitched together with a diagonally extending stitching line 94 parallel to the short edges 86, 88. The upper edge portion of the inner skirt 16 may be formed with a plurality of projections 96 defining a wave-like shape that generally follows the shape or contour of the fourth row of struts 28 immediately below the lower end of the axial struts 31. In this manner, as best shown in fig. 16, the upper edge of the inner skirt 16 may be fixedly secured to the post 28 with a suture 70. The inner skirt 16 may also be formed with slits 98 to facilitate attachment of the skirt to the frame. The slit 98 may be sized to allow the upper edge portion of the inner skirt 16 to wrap partially around the post 28 and reduce stresses in the skirt during attachment. For example, in the illustrated embodiment, the inner skirt 16 is placed inside the frame 12 and the upper edge portion of the skirt is wrapped around the upper surface of the post 28 and secured in place with a suture 70. Wrapping the upper edge portion of the inner skirt 16 around the struts 28 in this manner provides a stronger and more durable attachment of the skirt to the frame. The inner skirt 16 may also be secured to the first, second and/or third rows of struts 22, 24 and 26, respectively, with sutures 70.

Referring again to fig. 12, in this embodiment, the skirt may experience greater elongation in the axial direction (i.e., the direction from the upper edge 82 to the lower edge 84) due to the angled orientation of the fibers relative to the upper and lower edges.

Thus, when the metal frame 12 is crimped (as shown in fig. 13), the inner skirt 16 may be elongated in the axial direction with the frame and thus provide a more uniform and predictable crimping profile. Each mesh of the metal frame in the illustrated embodiment includes at least four angled struts that rotate toward the axial direction when crimped (e.g., the angled struts become more aligned with the length of the frame). The angled struts of each mesh act as a mechanism to rotate the fibers of the skirt in the same direction of the struts, allowing the skirt to elongate along the length of the struts. This allows for greater elongation of the skirt and avoids undesirable deformation of the struts as the prosthetic valve is crimped.

Furthermore, the spacing between the braided fibers or yarns may be increased to facilitate elongation of the skirt in the axial direction. For example, for a PET inner skirt 16 formed from 20 denier yarns, the yarn density may be about 15% to about 30% less than a conventional PET skirt. In some examples, the inner skirt 16 may have a yarn spacing of from about 60 yarns per centimeter (about 155 yarns per inch) to about 70 yarns per centimeter (about 180 yarns per inch), such as about 63 yarns per centimeter (about 160 yarns per inch), while in conventional PET skirts the yarn spacing may be from about 85 yarns per centimeter (about 217 yarns per inch) to about 97 yarns per centimeter (about 247 yarns per inch). The beveled edges 86, 88 promote a uniform and consistent distribution of the fabric material along the inner circumference of the frame during crimping so that uniform crimping is the smallest possible diameter. In addition, cutting the diagonal seam in a perpendicular fashion may leave loose fringes along the cut edge. The beveled edges 86, 88 help minimize this from happening.

In alternative embodiments, the skirt may be formed from braided elastic fibers that may stretch in the axial direction during crimping of the prosthetic valve. The warp and weft fibers may extend perpendicular to and parallel to the upper and lower edges of the skirt, or alternatively, as described above, they may extend at an angle of between 0 and 90 degrees relative to the upper and lower edges of the skirt.

The inner skirt 16 may be sewn to the frame 12 at a location remote from the seam 154 so that the skirt may be more flexible in this region. This configuration may avoid stress concentrations on the sutures 154 attaching the lower edge of the leaflet to the inner skirt 16.

As described above, the leaflet structure 14 in the illustrated embodiment includes three flexible leaflets 41 (although a greater or lesser number of leaflets may be used). Additional information about the leaflets and about the skirt material can be found, for example, in U.S. patent application No. 14/704861 filed on 5/2015.

The leaflets 41 can be secured to each other on their adjacent sides to form commissures 122 of the leaflet structure. A plurality of flexible connectors 124 (one of which is shown in fig. 17) may be used to interconnect adjacent sides of the paired leaflets and connect the leaflets to the commissure window frame portions 30 (fig. 5).

Figure 17 shows adjacent sides of two leaflets 41 interconnected by a flexible connector 124. As shown in fig. 18, three flexible connectors 124 may be used to secure three leaflets 41 to each other side-by-side. Additional information about the connection of the leaflets to each other and to the frame can be found, for example, in U.S. patent application publication No. 2012/0123599.

As described above, the inner skirt 16 may be used to assist in suturing the leaflet structure 14 to the frame. The inner skirt 16 may have undulating temporary marker sutures to guide the attachment of the lower edge of each leaflet 41. As described above, the inner skirt 16 itself may be sewn to the struts of the frame 12 using the sutures 70 prior to securing the leaflet structure 14 to the skirt 16. The struts intersecting the marker sutures are desirably unattached to the inner skirt 16. This allows the inner skirt 16 to be more flexible in the areas not secured to the frame and minimizes stress concentrations along the sutures that secure the lower edges of the leaflets to the skirt. As described above, when the skirt is secured to the frame, the fibers 78, 80 (see FIG. 12) of the skirt are generally aligned with the angled struts of the frame to promote uniform crimping and expansion of the frame.

Fig. 19 illustrates one particular method for securing the commissures 122 of the leaflet structure 14 to the commissure window frame portion 30 of the frame. In this approach, the flexible connector 124 (fig. 18) securing two adjacent sides of two leaflets is folded laterally and the upper tab portion 112 is folded down against the flexible connector. Each upper tab portion 112 is folded longitudinally (vertically) to assume an L-shape, with the first portion 142 folded against the surface of the leaflet and the second portion 144 folded against the connector 124. The second portion 144 may then be stitched to the connector 124 along the stitching 146. Next, the commissure tab assemblies are inserted through the commissure windows 20 of the respective window frame portions 30, and the folds outside of the window frame portions 30 can be stitched to the second portions 144.

Figure 19 also shows that the folded down upper tab portion 112 can form a double layer of leaflet material at the commissures. The first portion 142 of the upper tab portion 112 is positioned flat against the layers of the two leaflets 41 forming the commissures such that each commissure includes only four layers of leaflet material inside the window frame 30. These four-ply portions of the commissures may be more resistant to bending or hinging than portions of the leaflets 41 radially inward of only the relatively stiffer four-ply portions. This allows the leaflets 41 to hinge primarily at the inner edge 143 of the folded down portion 142, rather than around or near the axial struts of the window frame 30, in response to blood flowing through the prosthetic valve during in vivo operation. Because the small She Jiaojie is spaced radially inward from the window frame 30, the leaflets can avoid touching and damaging the frame. However, under high forces, the four-layer portions of the commissures may unfold about a longitudinal axis adjacent to the window frame 30, each first portion 142 folding outwardly against a respective second portion 144. This may occur, for example, when the prosthetic valve 10 is crimped and mounted onto a delivery shaft, allowing for a smaller crimp diameter. When the balloon catheter is inflated during expansion of the prosthetic valve, the four layer portions of the commissures may also expand about the longitudinal axis, which may relieve some of the pressure on the commissures caused by the balloon, thereby reducing potential damage to the commissures during expansion.

After all three commissure tab assemblies are secured to the respective window frame portions 30, the lower edges of the leaflets 41 between the commissure tab assemblies can be sewn to the inner skirt 16. For example, as shown in FIG. 20, each leaflet 41 may use, for example, ethibondThe wire is sewn to the inner skirt 16 along a suture 154. The sutures may be through sutures extending through each leaflet 41, inner skirt 16, and each reinforcement band 72. Each leaflet 41 and corresponding reinforcing band 72 may be separately sewn to the inner skirt 16. In this manner, the lower edges of the leaflets are secured to the frame 12 by the inner skirt 16. As shown in fig. 20, the leaflets may be further secured to the skirt with a lock stitch 156, the lock stitch 156 extending through each of the reinforcement band 72, the leaflets 41 and the inner skirt 16, while encircling the edges of the reinforcement band 72 and the leaflets 41. The lockstitch suture 156 may be formed from a PTFE suture material. Figure 21 shows a side view of the frame 12, the leaflet structure 14, and the inner skirt 16 after securing the leaflet structure 14 and the inner skirt 16 to the frame 12 and securing the leaflet structure 14 to the inner skirt 16.

Fig. 22-23 illustrate another embodiment of an outer skirt or sealing member 200 that may be incorporated into a prosthetic valve, such as valve 10. Fig. 22 shows a plan view of the outer skirt 200 prior to its attachment to the prosthetic heart valve. Fig. 23 shows a view of the outer skirt 200 in a cylindrical configuration prior to its attachment to a prosthetic heart valve.

Referring to fig. 22-23, the outer skirt 200 may include an upper edge portion 202, a lower edge portion 204, and an intermediate portion 206 disposed between the upper edge portion 202 and the lower edge portion 204. The intermediate portion 206 may include a plurality of vertical slits, cuts, or openings 208 cut or otherwise formed at circumferentially spaced locations in the outer skirt 200. Each pair of adjacent slits 208 define a vertical strip 210 (also referred to as a skirt section) therebetween such that there are a plurality of such strips 210, each strip 210 extending longitudinally along the length of the outer skirt 200 from the upper edge portion 202 to the lower edge portion 204. Each strap 210 in the illustrated embodiment defines opposing longitudinally extending edge portions 212 adjacent to the respective slit 208.

The outer skirt 200 may be formed of the following materials: synthetic materials, including woven, nonwoven, or nonwoven materials (e.g., foams, sheets) formed from any of a variety of suitable biocompatible polymers, such as PET, PTFE, ePTFE, polyurethane, polyester; natural tissue (pericardium); and/or other suitable materials configured to restrict and/or prevent blood flow therethrough. Alternatively, the outer skirt 200 may be formed of an elastic material. Slit 208 may be formed by laser cutting or any other suitable means. As described below in connection with fig. 24-25, the outer skirt 200 may be secured to the frame of a prosthetic heart valve.

The slit 208 in the illustrated embodiment is straight, thus defining a rectangular strip 210. However, in other embodiments, the slit 208 may have various other shapes, including curved portions, so as to define various shaped strips 210. For example, the slit 208 may have a wavy shape or a sinusoidal shape so as to define a strip 210 having longitudinal sides of the same shape. Further, as shown in the illustrated embodiment, the slit 208 terminates near the upper and lower edges of the skirt. In this way, the strips 210 are connected to each other at their upper and lower ends by the upper and lower edge portions 202, 204 of the skirt. In other embodiments, one or more slits 208 may extend all the way to the upper or lower edge of the skirt such that strips 210 are not connected to adjacent strips, with slits 208 extending all the way to the upper or lower edge of the skirt.

Fig. 24-25 illustrate the outer skirt 200 of fig. 22-23 mounted on the outside of the frame 12. Fig. 25 shows an enlarged view of a portion of the frame 12 and the outer skirt 200. The frame 12 and outer skirt 200 may be part of a prosthetic heart valve similar to the prosthetic heart valve 10, which may include a valve structure similar to the valve structure 14 and an inner skirt similar to the inner skirt 16, as best shown in fig. 1-3. For purposes of illustration, fig. 24-25 only show the frame 12 and the outer skirt 200.

As previously described and as best shown in fig. 5, the frame 12 includes struts 34 extending axially between the angled struts 22, 24 of rows I and II. The first row of struts I, the second row of struts II, and the axially extending struts 34 define a plurality of cells defining openings 36. Prior to attachment to the frame 12, the outer skirt 200 may be disposed about the outer surface of the frame 12 such that each slit 208 is adjacent to an axially extending strut 34 and such that each band 210 substantially covers one of the cell openings 36. The upper edge portion 202 and lower edge portion 204 of the outer skirt 200 may be secured to the frame 212 using suitable techniques and/or mechanisms, including sutures, adhesives, and/or ultrasonic welding. In particular embodiments, for example, the entire extent of lower edge portion 204 may be stitched to the I-row angled struts 22 of frame 12, while upper edge portion 202 may be stitched at the junction formed by the intersection of struts 26 and struts 28. In other embodiments, the entire extent of upper edge portion 202 may be stitched to either strut 26 or strut 28. In some embodiments, the upper edge portion 202 may have a wavy or scalloped shape, such as shown by skirt 18, and may be stitched to the frame 12, as shown in fig. 1.

In particular embodiments, the height H of the outer skirt 200 in the axial direction may be greater than the axial distance between the attachment locations of the upper and lower edge portions 202, 204 of the outer skirt 200 when the frame 12 is in the radially contracted configuration. In this manner, radial expansion of the frame 12 results in shortening of the frame 12 between the attachment locations of the skirt 200, creating slack in the skirt 200 between the attachment locations and allowing the straps 210 to move outwardly from the frame 12. In the example shown, the axial length of the outer skirt 200 is equal to the length of the struts 22 plus the length of the struts 34 plus the length of the struts 24 plus the length of the struts 26 of the frame 12. In alternative embodiments, the outer skirt 200 may have a different height H, depending on the particular application.

In addition to the upper and lower ends 202, 204 being secured to the frame 12, at least one of the longitudinal edge portions 212 of each of the plurality of straps 210 may be secured to the frame 12 and/or other straps to create circumferential and/or twisting movement of the straps 210 as the frame 12 radially expands. In the example shown, the strap 210 is secured to the frame 12 by a tether 214, which tether 214 may be, for example, a suture, flexible wire, filament, or similar material. Alternatively, the straps 210 may be secured to the frame 12 by adhesive and/or ultrasonic welding in addition to or in lieu of the suture.

In the illustrated embodiment, for each of the plurality of straps 210, the edge portion 212a may be secured to the post 34 by a tether 214, the tether 214 having one end 214a tied or knotted around the post 34 and the other end 214b tied to the strap 212. Desirably, the edge 212a of the strap 210 is secured to the brace 34 nearest the unsecured edge 212b of the same strap such that the tether 214 extends across the width of the strap 210 and unsecured edge 212 b. Thus, when the frame 12 is in the radially contracted configuration, the axially extending struts 34 are closer together, and the band 210 extends in a generally straight line between the upper and lower edges 202, 204 of the skirt 200. However, as the frame 12 expands to the radially expanded configuration, the axially extending struts 34 move away from each other, pulling the fixed edge 212a of each strap 210 toward its unsecured edge 212b, thereby reducing the width of the strap 210 between its upper and lower ends (the width of the strap extending in the circumferential direction) and creating a longitudinal fold in the strap 210. In this manner, the strips 210 form rib-like projections that may also extend radially outward from the frame 12 due to the shortening of the frame 12 as it radially expands.

In the illustrated embodiment, the tether 214 is positioned radially outward of the skirt 200. In some embodiments, the tether 214 may be positioned radially inside the skirt 200. In other embodiments, some of the tethers 214 may be positioned outside of the skirt 200 while other tethers 214 are positioned inside of the skirt 200. When a prosthetic valve (e.g., valve 10 with outer skirt 200) is implanted in a native annulus, the protrusions formed by the strips 210 can contact surrounding tissue and form a seal to prevent or minimize paravalvular leakage.

Fig. 26-27 illustrate another embodiment including a frame 12 and an outer skirt 200. The embodiment of fig. 26-27 is identical to the embodiment of fig. 24-25, except for the manner in which the skirt 200 is secured to the frame 12. As described above with respect to the embodiments of fig. 24-25, the embodiments of fig. 26-27 may include a valve structure, such as valve structure 14, and an inner skirt, such as inner skirt 16 (as best shown in fig. 1-3), to form a prosthetic heart valve. For purposes of illustration, fig. 26-27 only show the frame 12 and the outer skirt 200.

26-27, As previously described, the upper edge portion 202 and the lower edge portion 204 of the outer skirt 200 may be secured to the frame 12. The first longitudinal edge portion 212a of each strap 210 may be secured to the strut 34a adjacent to the second longitudinal edge portion 212b of the same strap 210 by a first tether 214. The first tether 214 extends across the width of the strap 210 and has a first end 214a that is tied or knotted around the strut 34a and a second end 214b that is secured to the edge portion 212 a. The second longitudinal edge portion 212b is secured to the post 34b adjacent the first edge portion 212a by a second tether 216. Second tether 216 extends across the width of the strap and has a first end 216a that is tied or knotted around post 34b and a second end 216b that is secured to second edge portion 212 b.

The tethers 214, 216 are desirably located on opposite sides of the skirt 200. As shown in the illustrated embodiment, the first tether 214 is positioned radially outside of the skirt 200, while the second tether 216 is positioned radially inside of the skirt 200. Thus, when the frame 12 expands to the radially expanded configuration (such that the struts 34a, 34b move away from one another), the first edge portion 212a is pulled toward the second edge portion 212b by the first tether 214 and the second edge portion 212b is pulled toward the first edge portion 212a. Pulling of the tethers 214, 216 reduces the width of the band 210 and creates a longitudinal fold, and also causes the band 210 to twist or rotate slightly as the tethers 214, 216 are located on opposite sides of the outer skirt 200. As previously mentioned, the bands 210 may also protrude radially from the frame 12 as the frame shortens, forming ribbed protrusions that may help seal the prosthetic valve to the native annulus. In alternative embodiments, the tethers 214, 216 may be on the same side of the skirt 200 (i.e., both tethers 214, 216 may be positioned radially outside of the skirt 200 or inside of the skirt 200), in which case the band 210 assumes a similar shape when the frame expands, but without twisting the opposing edge portions 212a, 212 b.

Fig. 28-29 illustrate another embodiment including a frame 12 and an outer skirt 200. The embodiment of fig. 28-29 is identical to the embodiment of fig. 24-25, except for the manner in which the skirt 200 is secured to the frame 12. As described above with respect to the embodiments of fig. 24-25, the embodiments of fig. 28-29 may include a valve structure, such as valve structure 14, and an inner skirt, such as inner skirt 16 (as best shown in fig. 1-3), to form a prosthetic heart valve. For purposes of illustration, fig. 28-29 only show the frame 12 and the outer skirt 200. In this embodiment, the skirt segments are coupled to one another by tethers (rather than struts of the frame) to create movement of the skirt segments as the frame radially expands.

28-29, As previously described, the upper edge portion 202 and the lower edge portion 204 of the outer skirt 200 may be secured to the frame 12. The outer skirt 200 includes a plurality of strips 210a and 210b alternately positioned about the outer surface of the frame 12, which are similar to the strips 210 of fig. 24-25 except how they are secured to the frame 12. The first longitudinal edge portion 212a of each strap 210a may be secured to the longitudinal edge portion 212c of an adjacent strap 210b by a first tether 218. First tether 218 may extend across the width of straps 210a and 210b and may have a first end 218a secured to edge portion 212c and a second end 218b secured to edge portion 212 a. The second longitudinal edge portion 212b of each strap 210a may be secured to the longitudinal edge portion 212d of an adjacent strap 210b on the other side of the strap 210a by a second tether 220. The second tether 220 may extend across the width of the straps 210a and 210b and may have a first end 220a secured to the edge portion 212b and a second end 220b secured to the edge portion 212d. In this manner, each strap 210a is coupled to two straps 210b located on opposite sides of strap 210a by tethers 218, 220. Each strap 210b may be coupled to two straps 210a in the same manner.

Tethers 218, 220 are desirably located on opposite sides of skirt 200. As shown in the illustrated embodiment, first tether 218 is positioned radially inside skirt 200, while second tether 216 is positioned radially outside skirt 200. Thus, when the frame 12 expands to the radially expanded configuration, the edge portions 212a, 212c of the straps 210a, 210b, respectively, are drawn inwardly toward each other, while the edge portions 212b, 212d of the straps 210a, 210b, respectively, are drawn outwardly toward each other. Pulling of the straps 210a, 210b causes the width of the straps 210a, 210b to decrease and form a longitudinal fold, and also causes the straps 210a, 210b to twist or rotate slightly as a result of the tethers 218, 220 being located on opposite sides of the outer skirt 200. As previously mentioned, the bands 210a, 210b may also protrude radially from the frame 12 as the frame shortens, forming ribbed protrusions that may help seal the prosthetic valve to the native annulus. In alternative embodiments, tethers 218, 220 may be on the same side of skirt 200 (i.e., both tethers 218, 220 may be positioned radially outside of skirt 200 or inside of skirt 200), in which case straps 210a, 210b take on a similar shape when the frame expands, but without twisting the opposing edge portions 212a, 212b, 212c, 212 d.

In the embodiment of fig. 28-29, each edge portion of a strip is coupled to the furthest edge portion of an adjacent strip. In alternative embodiments, each edge portion of a strip may be coupled to a closer edge portion of an adjacent strip. For example, edge portion 212a of strap 210a may be coupled to edge portion 212d of one strap 210b by tether 218, while edge portion 212b may be coupled to edge portion 212c by tether 220 of another strap 210 b. In other embodiments, the different techniques described above for coupling the skirt strips to the frame struts and to each other may be combined in a single prosthetic valve. For example, the skirt 200 may have some straps coupled to the frame struts in the manner shown in fig. 24-25, some straps coupled to the frame struts in the manner shown in fig. 26-27, and some straps coupled to each other in the manner shown in fig. 28-29 and/or described above.

In alternative embodiments, instead of having a single skirt mounted on the outside of the frame, the outer sealing member may comprise a plurality of discrete sealing segments positioned side by side around the circumference of the frame. For example, instead of cutting the slit 208 in the skirt 200, the skirt 200 may be cut along a cutting line extending from the lower edge to the upper edge at the position of the slit 208 in fig. 22 to form a plurality of rectangular seal segments. Each discrete seal segment may be secured to the frame at upper and lower edge portions thereof. Each discrete seal segment may be coupled to the frame and/or one or more other seal segments by using one or more tethers of any of the configurations described above.

The prosthetic valve 10 can be configured and mounted on a suitable delivery device for implantation in a patient. Several catheter-based delivery devices may be used; non-limiting examples of suitable catheter-based delivery devices include those disclosed in U.S. patent application publication No.2013/0030519 and U.S. patent application publication No. 2012/0123599.

In one example, to implant the plastically-expandable prosthetic valve 10 in a patient, the prosthetic valve 10 including the frame 12 and the outer skirt 200 may be crimped onto the elongate shaft 180 of the delivery device, as best shown in fig. 13. The prosthetic valve may form a delivery assembly with a delivery device for implanting the prosthetic valve 10 into a patient. The shaft 180 includes an inflatable balloon 182 for expanding the prosthetic valve in vivo. Following deflation of the balloon 182, the prosthetic valve 10 can then be delivered percutaneously to a desired implantation site (e.g., a native aortic valve region). Once the prosthetic valve 10 is delivered to an implantation site in the body (e.g., a native aortic valve), the prosthetic valve 10 can be radially expanded to its functional state by inflating the balloon 182.

Alternatively, the self-expanding prosthetic valve 10 may be crimped into a radially contracted configuration and restrained in the contracted configuration by inserting the prosthetic valve 10 comprising the frame 12 and outer skirt 200 into a sheath or equivalent mechanism of a delivery catheter. The prosthetic valve 10 can then be delivered percutaneously to the desired implantation site. Once inside the body, the prosthetic valve 10 can be advanced from the delivery sheath, which allows the prosthetic valve 10 to expand to its functional state.

Fig. 30-32 and 35 illustrate various implantation locations of the prosthetic heart valve 10 (with an outer skirt 200 instead of the outer skirt 18 described above in connection with fig. 24-29), including implantation into a docking portion or anchor placed within a patient prior to valve implantation. In the embodiment shown in fig. 30-31, the outer skirt 200 is configured in the manner described in connection with fig. 24-25. In other embodiments, the outer skirt 200 of FIGS. 30-31 may be configured in the manner described in connection with FIGS. 26-27 or in the manner described in connection with FIGS. 28-29. Fig. 30 shows a prosthetic heart valve 10 implanted in a native aortic valve of a patient.

Fig. 31 shows a prosthetic heart valve 10 implanted in a patient's pulmonary artery for replacing or enhancing the function of a diseased pulmonary valve. The prosthetic valve 10 may be implanted in a radially expandable external docking device 300 due to variations in the size and shape of the native pulmonary valve and pulmonary artery. The interface 300 may include a radially expandable and compressible annular stent 302 and a sealing member 304, the sealing member 304 covering all or a portion of the stent and may extend across an inner and/or outer surface of the stent. The docking device 300 is configured to engage the inner wall of the pulmonary artery and can accommodate changes in patient anatomy. The docking device 300 may also compensate for the expanded prosthetic heart valve 310 being much smaller than the vessel in which it is placed. The docking device 300 may also be used to support a prosthetic valve in other areas of the patient's anatomy, such as the inferior vena cava, superior vena cava, or aorta. Further details of the docking device 300 and methods for implanting the docking device and prosthetic valve are disclosed in co-pending U.S. application No.15/422354, filed on, for example, month 2 and 1 of 2017.

Fig. 32 shows a prosthetic heart valve 10 implanted in a patient's native mitral valve using a docking device in the form of a helical anchor 400. The helical anchor 400 may include one or more coils 402 disposed in the left atrium and one or more coils 404 disposed in the left ventricle and radially outward of the native mitral valve leaflet 406. When the prosthetic valve 10 is deployed within the native valve, the native valve is compressed or sandwiched between the prosthetic valve 410 and the anchor 400 to hold the prosthetic valve in place. Further details of the helical anchor 400 and the method for implanting the anchor and prosthetic valve are disclosed in co-pending U.S. application No.62/395940, filed on, for example, date 2016, 9, 16.

Fig. 33 and 34 illustrate a docking device 500 for a prosthetic heart valve according to another embodiment. Docking device 500 may include a radially expandable and compressible frame 502, with frame 502 having an outer portion 504, an inner portion 506 coaxially disposed within an end of outer portion 504, and a curved transition portion 508 extending between and connecting inner portion 506 and outer portion 504. The interface 500 may also include a sealing member 510 extending over an inner surface of the inner portion 506, a portion of an outer surface of the outer portion 504 adjacent the inner portion 506, and a transition portion 508.

Fig. 35 shows the docking device 500 implanted in a blood vessel 520, which vessel 520 may be, for example, the inferior vena cava, superior vena cava, or ascending aorta. As shown, the prosthetic valve 10 can be disposed within the interior portion 1606 of the docking device 500. Similar to the docking device 300, the docking device 500 may compensate for the expanded prosthetic heart valve 10 being much smaller than the vessel in which it is placed. The docking device 500 is particularly suited for implantation of a prosthetic valve in the inferior vena cava to replace or augment the function of the native tricuspid valve. Further details of the docking device 500 and methods for implanting the docking device and prosthetic valve are disclosed in co-pending U.S. application No.16/034794, filed on, for example, day 13, 7, 2018.

General considerations

It should be appreciated that the disclosed valve may be implanted in any native annulus of the heart (e.g., the pulmonary valve annulus, the mitral valve annulus, and the tricuspid valve annulus), and may be used with any of a variety of methods (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.). The disclosed prosthesis may also be implanted in other lumens of the body.

For purposes of description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and nonobvious features and aspects of the various disclosed embodiments, both separately and in various combinations and subcombinations with one another. The methods, apparatus and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.

Although the operations of some of the disclosed embodiments are described in a particular order for ease of presentation, it should be understood that this manner of description includes rearrangement, unless a particular order is required by the particular language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods.

As used in this specification and the claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Furthermore, the term "comprising" means "including.

As used herein, the term "and/or" as used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B and/or C" means "a", "B", "C", "a and B", "a and C", "B and C" or "A, B and C".

As used herein, the term "proximal" refers to the location, direction, or portion of the device that is closer to the user and further from the implantation site. As used herein, the term "distal" refers to the location, direction, or portion of the device that is distal to the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device toward the user, while distal movement of the device is movement of the device away from the user. The terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions unless explicitly defined otherwise.

As used herein, the terms "coupled" and "associated" generally mean physically coupled or linked, and do not exclude the presence of intermediate elements between coupled or associated items in the absence of a particular reverse language.

As used herein, operations that occur "concurrently" or "concurrently" generally occur concurrently with each other, although delays in one operation relative to another operation due to, for example, spacing, play or clearance between components in a mechanical connection (such as threads, gears, etc.) are well within the scope of the above terms and are not specifically to the contrary.

In view of the many possible embodiments to which the principles disclosed herein may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the present disclosure. Rather, the scope of the present disclosure is at least as broad as the following claims.

Claims

1. An implantable prosthetic valve, comprising:

An annular frame including an inflow end and an outflow end and being radially contractible and expandable between a radially contracted configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end;

a leaflet structure positioned within and secured to the frame; and

An outer sealing member positioned about an outer surface of the frame, wherein the outer sealing member comprises a plurality of sealing segments, wherein each sealing segment extends longitudinally in the axial direction between an upper edge portion and a lower edge portion of the outer sealing member; and

Wherein each seal segment is coupled to the frame and/or another seal segment by at least a first tether that pulls a portion of the seal segment in a circumferential direction when the frame is radially expanded to the radially expanded configuration such that the seal segment decreases in width between its upper and lower ends in the circumferential direction and forms a longitudinal fold in the seal segment.

2. The implantable prosthetic valve of claim 1, wherein the portion of the sealing segment is one of a first longitudinal edge portion and a second longitudinal edge portion of the sealing segment.

3. The implantable prosthetic valve of claim 1, wherein the first tether is coupled to a first longitudinal edge portion of the sealing segment.

4. The implantable prosthetic valve of claim 3, wherein each sealing segment is coupled to the frame and/or another sealing segment by a second tether that pulls a second longitudinal edge portion of the sealing segment in the circumferential direction when the frame is radially expanded to the expanded configuration.

5. The implantable prosthetic valve of claim 4, wherein the first tether and the second tether are disposed on opposite sides of the outer sealing member.

6. The implantable prosthetic valve of claim 4, wherein the first tether and the second tether are disposed on opposite sides of the outer sealing member in a radial direction.

7. The implantable prosthetic valve of claim 1, wherein each seal segment has an upper portion and a lower portion connected to the frame at axially spaced locations on the frame, the upper and lower portions moving toward each other upon radial expansion of the frame and causing a portion of the seal segments to move radially outward away from the frame.

8. The implantable prosthetic valve of claim 1, wherein a width of each sealing segment in a circumferential direction is reduced upon radial expansion of the frame by a pulling force of a tether connected to the sealing segment.

9. The implantable prosthetic valve of claim 7, wherein a width of each sealing segment in a circumferential direction is reduced by a pulling force of a tether connected to the sealing segment as the frame radially expands.

10. The implantable prosthetic valve of claim 1, wherein each sealing segment becomes at least partially distorted upon radial expansion of the frame by a pulling force of a tether connected to the sealing segment.

11. The implantable prosthetic valve of claim 1, wherein each tether has one end secured to a sealing segment and another end secured to the frame or another sealing segment.